First cancer patient included in PCI Biotech's Phase I/II trial of
Amphinex®
(Thomson Reuters ONE) - Oslo, 24 August 2009 - PCI Biotech Holding ASA today announced thatthe first cancer patient has received treatment in the Phase I/IItrial with the lead candidate Amphinex®, used in PCI Biotech's uniquetechnology for targeted enhancement of therapeutics in cancertreatment. The patient was treated at the University College Hospital(UCH) in London. PCI's proprietary photosensitiser Amphinex® is inthis study combined with the cytotoxic agent bleomycin. Whenactivated by light, Amphinex® promotes effective delivery of largetherapeutic molecules such as bleomycin through triggered endosomalrelease. The trial will investigate a broadly representative spectrumof cancers including breast and head & neck cancer, to demonstratethe safety and potential of this new approach.The primary objective of this study is to assess the maximumtolerated dose of Amphinex®, in PCI treatment with bleomycin.Secondary objectives include determination of the antitumor activityof Amphinex® when used in combination with bleomycin, as well as itspharmacokinetics.Dr. Colin Hopper, Principal Investigator at UCH, said: "At UCH we arededicated to high quality patient care and we have extensiveexperience in the use of photodynamic therapy to treat cancerpatients. PCI is a very exciting new approach in photodynamicmedicine that has shown great promise in preclinical studies. We arevery proud of being the first centre to move this new technology intothe clinic."Per Walday CEO of PCI Biotech, comments: "This first in man trial isan important step forward for the company. We are confident that ourapproach addresses one interlinked major challenge in oncology - howto deliver therapeutics with large enough loads to effectivelydestroy tumours while at the same time reducing the risk of damaginghealthy cells. Bleomycin is ideal for demonstrating this - there isno doubt about its therapeutic potential, but until now deliveryproblems and associated toxicity have prevented the realisation ofits full potential. We expect to have preliminary results of thetrial early in 2010."In addition, whilst our main initial focus is cancer, we stronglybelieve the PCI technology also has potential to improve the effectof emerging treatments such as gene therapy and therapies based onnanotechnology or on biotechnological principles. In particular, weare looking at siRNA through projects funded by EU and by theNorwegian Research Council."-ends-.Notes to editorsPCI BiotechPCI Biotech is a Norwegian biopharmaceutical company developing anovel light directed drug delivery system based on its patentedphotochemical internalisation (PCI) technology. Originating fromworld leading research at the Norwegian Radium Hospital, the PCImethod involves first injecting target cells with a photosensitiser.Therapeutic molecules are then delivered to the cells and when theseare illuminated the cells' endosomes are ruptured to allow successfuluptake.PCI can enhance the delivery of all molecules taken into the cell byendocytosis. This includes most types of macromolecules, drugscarried by antibodies or nanoparticles, as well as some smallmolecule drugs. In addition, PCI enables the use of more toxiccompounds by restricting their effects to the target site.PCI Biotech follows a dual strategy of using its technology toimprove the effect both of existing drugs and for emerging treatmentssuch as gene therapy. PCI Biotech's first clinical study couples theproven photosensitiser Amphinex® with the cytotoxic agent bleomycin.Other studies are planned for the delivery of other cancer drugs inrelevant indications.For more information visit: www.pcibiotech.comContact information:PCI Biotech Holding ASA, Hoffsveien 48, N-0377 Oslo v/Per Walday, CEO, pw(at)pcibiotech.no, Mobile: +47 917 93 429Bernt-Olav Røttingsnes, CFO, bor(at)pcibiotech.no, Mobile: +47 913 47021This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 24.08.2009 - 08:02 Uhr
Sprache: Deutsch
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